Biotech regulatory environment has improved, report finds

By Alaric DeArment

SAN FRANCISCO — Biotech companies saw a decline in project delays due to regulations over the past year, as more than half have said insurance coverage and reimbursement issues have become more difficult, according to a new report.

"California continues to deliver life-saving treatments and new technologies that offer hope for patients in need," CHI president and CEO David Gollaher said. "Last year alone, we saw the approval of novel medicines to treat rare forms of cancer, anemia associated with chronic kidney disease and cystic fibrosis, among others."

The report found that California-based companies developed nine of the 32 new drugs that the Food and Drug Administration approved in 2012, while the industry is at the top in the number of jobs, new treatments for patients, venture capital investments and federal funding from the National Institutes of Health.

"As the center of biomedical innovation in the U.S., California's biomedical industry is a national treasury," BayBio president and CEO Gail Maderis said. "But the pace of R&D productivity and its global leadership position hang on the availability of capital to fund future innovation and a regulatory framework that is based on consistency and innovative technologies."

The report includes a survey of 175 biomedical company CEOs, nearly 14% of whom said that the FDA regulatory process had improved over the prior year, while the number who reported project delays due to regulation declined by 17%, to 16% in 2012. At the same time, 59% cited limited or lack of access to capital as the most threatening issue, while nearly 90% said they considered the industry's relationship with the FDA "extremely important," but 57% said regulatory processes hadn't kept pace with advances in science and technology, posing a risk to innovation.